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- 2024-09-04Detailed Description: Provide a thorough description of the medical device, including its design, functionality, and intended use.
- Submissions with complete and accurate information are processed more quickly. Incomplete or incorrect applications may lead to delays.
- Ensure that the medical device is correctly classified as Class A according to SFDA guidelines. Class A devices are generally low-risk and may include items such as basic medical equipment and instruments.
- Go to the SFDA Unified Electronic Platform (UAE) through SFDA Portal.
- Device Description: Detailed overview of the device, including its design, functionality, and intended use.
- Device Classification: Verify that your device is classified as Class A according to SFDA guidelines.
- Go to the SFDA Unified Electronic Platform (UAE) website. You can access it via SFDA Portal.
- The cost for registering a Class A medical device with the SFDA is typically lower than for higher-risk classes. The exact fee can vary, so it's best to consult the SFDA’s fee schedule or contact their support for the most current rates.
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